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FDA 510(k)

Portable Slit Lamp

K-Number: K153545 · 2016-06-22

ApplicantShanghai Bolan Optical-Electric Co., Ltd.
Decision Date2016-06-22
Product CodeHJO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Portable Slit Lamp is a medical device manufactured by Shanghai Bolan Optical-Electric Co., Ltd.. It received FDA 510(k) clearance on 2016-06-22 under approval number K153545. The device is classified under product code HJO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Portable Slit Lamp?

Portable Slit Lamp is a medical device that received FDA 510(k) clearance on 2016-06-22. It is manufactured by Shanghai Bolan Optical-Electric Co., Ltd.. The 510(k) number is K153545.

When was Portable Slit Lamp approved by the FDA?

Portable Slit Lamp received FDA 510(k) clearance on 2016-06-22, under approval number K153545.

What company makes Portable Slit Lamp?

Portable Slit Lamp is manufactured by Shanghai Bolan Optical-Electric Co., Ltd..

What is the FDA product code for Portable Slit Lamp?

The FDA product code for Portable Slit Lamp is HJO.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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